MAUDE Adverse Event Report: HTL-STREFA S.A. MEMBER'S MARK PEN NEEDLE

Model Number	31G X 6MM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Pen needles do not feel sharp and do not easily puncture the skin and bend easily.

• Brand Name: MEMBER'S MARK PEN NEEDLE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 8614545
• Report Number: 9613304-2019-00057
• Device Sequence Number: 2180946
• Product Code: FMI
• UDI-Device Identifier: 10078742257744
• UDI-Public: (01)10078742257744(17)230701(10)Y46ZA6
• Combination Product (Y/N): N
• PMA/510(K) Number: K143437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/01/2023
• Device Model Number: 31G X 6MM
• Device Catalogue Number: 8932
• Device Lot Number: Y46ZA6
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2019
• Initial Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1